# US 9,751,944 B2 · Anti-Siglec-15 antibody

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- Number: US 9,751,944 B2
- Document ID: US9751944B2
- Status: Granted
- Kind: B2
- Application number: 14/731,519
- Filed: 2015-06-05
- Published: 2015-10-22
- Granted: 2017-09-05
- Earliest claimed: 2009-04-09
- Assignees: Daiichi Sankyo Company, Limited
- Applicants: Daiichi Sankyo Company, Limited
- Inventors: Yoshiharu Hiruma; Eisuke Tsuda; Takeshi Takizawa; Makiko Nakayama
- Web page: https://patentgrep.com/patent/US9751944B2

## CPC

- C07K 16/2803: {against the immunoglobulin superfamily}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 3/14: for calcium homeostasis (vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04)
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/30: characterized by aspects of specificity or valency
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Provided is a pharmaceutical composition for treating and/or preventing abnormal bone metabolism targeting a protein encoded by a gene strongly expressed in osteoclasts. Specifically provided is a pharmaceutical composition containing an antibody which specifically recognizes human Siglec-15 and has an activity of inhibiting osteoclast formation, and the like.

## Claims

### Claim 1

A pharmaceutical composition comprising an antibody or antigen binding fragment thereof in an amount effective to inhibit osteoclast differentiation, wherein the antibody or antigen binding fragment comprises: a light chain sequence that comprises a light chain variable region having CDRL1, CDRL2, and CDRL3, wherein CDRL1, comprises the amino acid sequence of SEQ ID NO: 47, CDRL2, comprises the amino acid sequence of SEQ ID NO: 48, and CDRL3, comprises the amino acid sequence of SEQ ID NO: 49, and a heavy chain sequence that comprises a heavy chain variable region having CDRH1, CDRH2, and CDRH3, wherein CDRH1 comprises the amino acid sequence of SEQ ID NO: 44, CDRH2 comprises the amino acid sequence selected from the group consisting of SEQ ID NO: 45 and SEQ ID NO: 97, and CDRH3 comprises the amino acid sequence of SEQ ID NO: 46, wherein the antibody or antigen binding fragment thereof binds a Siglec-15 protein comprising the amino acid sequence of SEQ ID NO: 2 or 4, and a pharmaceutically acceptable excipient.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the antigen binding fragment is an scFv.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the antibody is a chimeric antibody.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, wherein the antibody or antigen binding fragment is humanized.

### Claim 5 (depends on 1)

The pharmaceutical composition of claim 1, wherein CDRH2 comprises the amino acid sequence of SEQ ID NO: 45.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, wherein CDRH2 comprises the amino acid sequence of SEQ ID NO: 97.

### Claim 7 (depends on 1)

The pharmaceutical composition of claim 1, wherein the excipient comprises a liquid or a solid.

### Claim 8 (depends on 1)

The pharmaceutical composition of claim 1, wherein the excipient comprises one or more of water, physiological saline, artificial cerebrospinal fluid, and albumin.

### Claim 9 (depends on 1)

The pharmaceutical composition of claim 1, wherein the composition is formulated for oral or parenteral administration.

### Claim 10 (depends on 1)

The pharmaceutical composition of claim 1, wherein the dosage form of the composition is an infusion, a suppository, a transnasal agent, a sublingual agent, or a percutaneous absorbent.